{"id":8679,"date":"2020-11-09T17:14:16","date_gmt":"2020-11-09T17:14:16","guid":{"rendered":"https:\/\/adhc.lib.ua.edu\/pandemicbook\/?page_id=8679"},"modified":"2021-11-14T19:51:16","modified_gmt":"2021-11-14T19:51:16","slug":"11-09","status":"publish","type":"page","link":"https:\/\/adhc.lib.ua.edu\/pandemicbook\/11-09\/","title":{"rendered":"11-09"},"content":{"rendered":"\t\t
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Monday, November 9<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tUS Cases 10.21 million
US Deaths 240,297<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Nov 8: George W. Bush congratulates<\/a> Biden on his win, while Trump refuses to concede. Total U.S. COVID cases reaches<\/a> 10 million.\u00a0<\/p>

Nov 9: Pfizer releases data from its COVID-19 vaccine trial showing that the vaccination was 90% effective. The FDA\u00a0issues an EUA for Eli Lilly\u2019s bamlanivimab,<\/a> a monoclonal antibody treatment that mimics the immune system\u2019s response to infection with SARS-CoV-2 and appears to protect high-risk patients with COVID-19 from progressing to more severe forms of the disease.\u00a0 The Dow Jones Industrial Average soars<\/a> in the wake of the news. Senate Majority Leader Mitch McConnell (R-Ky.) backs<\/a> President Trump’s refusal to recognize President-elect Joe Biden’s election victory. Attorney General William Barr authorizes federal prosecutors to investigate “specific allegations” of voter fraud\u00a0<\/a>before presidential election results are certified. The Trump White House tells administration leaders not to cooperate with President-elect Joe Biden’s transition team.\u00a0<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\tFrom the Cutting Room Floor...\t\t\t\t<\/span>\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\u201cToday is a great day for science and humanity,\u201d proclaims Dr. Albert Bourla, CEO and Chair of Pfizer, the pharmaceutical giant. Early this morning, his company announces its SARS-CoV-2 vaccine trial conducted with partner BioNTech is 90% effective.[1]<\/a> The news media erupts with heartfelt stories juxtaposing fears about the current increase in cases around the world with the promise of \u201cmillions of doses\u201d of Pfizer\u2019s vaccine in the next few months. University of Pennsylvania\u2019s Dr. Paul Offit\u2014the member of FDA\u2019s vaccine advisory panel who proclaimed on CNN in early March that, \u201cIt\u2019s really fear that we have to combat more than the [corona]virus itself\u201d\u2014welcomes the news.[2]<\/a> And he\u2019s not alone. At least at first, the Trump group cheers along as well, even though Biden\u2019s team is more cautious. Ken Farnaso, Deputy National Press Secretary claims this is part of \u201cOperation Warp Speed,\u201d the plan to dump money into the pharma companies in exchange for a vaccine. But it turns out Pfizer never got \u201cWarp Speed\u201d funds to make their vaccine; Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer maintained that they wanted to stay free from political entanglements, only taking government money to mass produce the already instantiated vaccine, not when developing it.[3]<\/a> The Twitterverse jumps on the false claim by Farnaso and by VP Pence, who parrots him.[4]<\/a><\/span><\/p>\n

As the day goes on, however, Trump supporters move from cheering to fuming. It\u2019s not just that they want credit. Starting with one of the president\u2019s sons, they insinuate that Pfizer withheld this information until after the election in order to hurt Trump —  should be investigated for election interference. Pfizer\u2019s announcement undercuts this possibility, since their analysis wasn\u2019t conducted until just yesterday. On the contrary, Pfizer was already seeking Emergency Use Authorization from the FDA before the election. And with their stock slightly down this year, they\u2019re promoting this \u201c90% effective\u201d news as loudly as they can, and their stock price is showing it.[5]<\/a><\/span>
[read_more id=”1″ more=”Read more” less=”Read less”]<\/p>\n

Fewer journalists ask whether the hype around Pfizer\u2019s announcement is warranted. It makes sense to be hopeful but circumspect. Pfizer released their claims in a press release; there\u2019s no peer-reviewed study yet, unlike in August when they published the results of their BNT162b1 Phase I\/II trial in <\/span>Nature<\/em>.<\/span>[6]<\/a> What that press-friendly account tells is pretty typical for an intermediate vaccine trial. For example, it tells us that Pfizer began the third phase of their BNT162b2 trial (they don\u2019t tell us what happened to the BNT162b1) on July 27<\/span>th<\/sup>. They also tell us that, as of yesterday, November 8th, 38,955 have received a second dose of the BNT162b2 vaccine candidate. Pfizer openly admits they released their data after only 94 people had been exposed and analyzed by an unidentified \u201cexternal, independent Data Monitoring Committee (DMC).\u201d<\/span>[7]<\/a> In fact, Pfizer\u2019s \u201cprimary efficacy endpoint\u201d\u2014in other words, the way they measure success\u2014is 7 days after the second dose of the vaccine, which is administered three weeks after the first dose. This delivery method is a full week faster than any of the other vaccine trials of its type. It\u2019s also a completely untried bio-delivery mechanism. The vaccine operates by inserting a \u201cnucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD).\u201d<\/span>[8]<\/a> In other words, the vaccine triggers the immune system to create antibodies to the spike protein on the outside of the coronavirus that allows it to infect us and gives it the \u201ccrown\u201d in its name.<\/span><\/p>\n

It\u2019s a hopeful story, and more data is expected soon to support the vaccine. Still, the scientific community urges caution. Aside from Dr. David Gorski, who questioned the trustworthiness of the CDC and FDA, given its pollution by Trump political appointees, one of the most important voices pulling back on the reins belongs to Dr. Michael Osterholm, director of the University of Minnesota\u2019s Center for Infectious Diseases Research and Policy. Osterholm appeared on Joe Rogan\u2019s podcast warning about coronavirus and refuting the \u201cflu is worse\u201d counternarrative back on March 10th<\/sup>. Osterholm is excited about the vaccine, as we all are. He also reminds us that Pfizer and BioNTech have not released information on whether the vaccine prevents COVID-19 cases that can lead to hospitalization and death. Nor have they told us whether their vaccine prevents those without symptoms from becoming unknowing spreader of disease. Basically, \u201cit\u2019s too early to start predicting how much of an impact the vaccine could make,\u201d Osterholm warns.[9]<\/a> And, even if it is actually 90% effective\u2014even Pfizer and BioNTech try to dampen that hope with a helpful \u201cthe final vaccine efficacy percentage may vary\u201d\u2014that doesn\u2019t account for how the vaccine will be manufactured.[10]<\/a> A major confounding factor, left unannounced by most media outlets today, is that the BNT162b2 vaccine requires storage of minus-70\u02daC (minus-120\u00baF). This is a temperature below the capabilities of most freezers at, say, physician\u2019s offices or hospitals.[11]<\/a> It creates a cold storage supply chain issue. So, while the news media sees hope for an effective vaccine under a Biden administration, the most informed scientists recognize that we still have some serious hurdles to overcome.[12]<\/a> We are a wealthy nation, capable of throwing great force at a problem when we want to. Hopefully, the efforts made to develop the vaccine can now be directed to manufacturing and distributing it. <\/span><\/p>


<\/span><\/p>\n

Notes<\/p>\n

[1]<\/a> \u201cPfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study,\u201d Business Wire<\/em>, November 9, 2020, https:\/\/www.businesswire.com\/news\/home\/20201109005539\/en\/%C2%A0Pfizer-and-BioNTech-Announce-Vaccine-Candidate-Against-COVID-19-Achieved-Success-in-First-Interim-Analysis-from-Phase-3-Study<\/a>.<\/span><\/p>\n

[2]<\/a> Azeen Ghorayshi and Dan Vergano, \u201cPfizer\u2019s Coronavirus Vaccine Is More Than 90% Effective, Early Data Says,\u201d BuzzFeed News, November 9, 2020, https:\/\/www.buzzfeednews.com\/article\/azeenghorayshi\/coronavirus-vaccine-pfizer-results<\/a>; \u201cPfizer Says Its Coronavirus Vaccine Is 90 Percent Effective,\u201d TODAY.com, November 9, 2020, https:\/\/www.today.com\/video\/pfizer-says-its-coronavirus-vaccine-is-90-percent-effective-95576133567<\/a>.<\/span><\/p>\n

[3]<\/a> Katie Thomas, David Gelles, and Carl Zimmer, \u201cPfizer\u2019s Early Data Shows Vaccine Is More Than 90% Effective,\u201d The New York Times<\/em>, November 9, 2020, sec. Health, https:\/\/www.nytimes.com\/2020\/11\/09\/health\/covid-vaccine-pfizer.html<\/a>.<\/span><\/p>\n

[4]<\/a> David Badash, \u201c\u2018Era of Lying Is over\u2019: Mike Pence Pummeled for Wrongly Handing Trump Credit for Pfizer COVID Vaccine,\u201d Rawstory, November 9, 2020, https:\/\/www.rawstory.com\/2020\/11\/era-of-lying-is-over-mike-pence-pummeled-for-wrongly-handing-trump-credit-for-pfizer-vaccine\/<\/a>.<\/span><\/p>\n

[5]<\/a> CBS\/AP, \u201cPfizer Will Seek Emergency-Use Authorization for COVID-19 Vaccine,\u201d CBS News, October 27, 2020, https:\/\/www.cbsnews.com\/news\/covid-vaccine-pfizer-emergency-use-authorization-fda\/<\/a>.<\/span><\/p>\n

[6]<\/a> Mark J. Mulligan et al., \u201cPhase I\/II Study of COVID-19 RNA Vaccine BNT162b1 in Adults,\u201d Nature<\/em> 586, no. 7830 (October 22, 2020): 589\u201393, https:\/\/doi.org\/10.1038\/s41586-020-2639-4<\/a>.<\/span><\/p>\n

[7]<\/a> Pfizer, \u201cPfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study,\u201d Pfizer Inc. Pressroom, November 9, 2020, https:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/pfizer-and-biontech-announce-vaccine-candidate-against<\/a>.<\/span><\/p>\n

[8]<\/a> Mulligan et al., \u201cPhase I\/II Study of COVID-19 RNA Vaccine BNT162b1 in Adults,\u201d 162.<\/span><\/p>\n

[9]<\/a> Matthew Herper, \u201cCovid-19 Vaccine from Pfizer and BioNTech Is Strongly Effective, Data Show,\u201d STAT<\/em>, November 9, 2020, https:\/\/www.statnews.com\/2020\/11\/09\/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate\/<\/a>.<\/span><\/p>\n

[10]<\/a> Pfizer, \u201cPfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.\u201d<\/span><\/p>\n

[11]<\/a> Beth Mole, \u201cHere\u2019s Everything You Need to Know about Pfizer\u2019s Positive Vaccine News,\u201d Ars Technica<\/em>, November 9, 2020, https:\/\/arstechnica.com\/science\/2020\/11\/heres-everything-to-know-about-pfizers-positive-vaccine-news\/<\/a>.<\/span><\/p>\n

[12]<\/a> Ewen Callaway, \u201cWhat Pfizer\u2019s Landmark COVID Vaccine Results Mean for the Pandemic,\u201d Nature<\/em>, November 9, 2020, https:\/\/doi.org\/10.1038\/d41586-020-03166-8<\/a>; Hannah Osborne, \u201cPfizer COVID Vaccine\u2014Scientists React with Caution and Questions,\u201d Newsweek, November 9, 2020, https:\/\/www.newsweek.com\/covid-vaccine-pfizer-scientists-cautious-questions-1546018<\/a>.<\/span> [\/read_more]<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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“Election Results 2020,” Last Week Tonight with John Oliver, HBO, November 9, 2020, https:\/\/youtu.be\/LyC855KdBKo<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Donie O’Sullivan, “These Trump supporters think the election was stolen. We ask them why,” CNN, November 9, 2020, https:\/\/youtu.be\/mc7_GzMOodY<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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